intrahepatic cholangiocarcinoma
Conditions
Interventions
experimental group:nab-paclitaxel + S-1 + PD-1 inhibitor
Sponsors
Xiangyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years old; 2. Patients with advanced hepatic cholangiocarcinoma who are in strict compliance with the "Chinese Expert Consensus on Surgical Treatment of Intrahepatic Cholangiocarcinoma" (2020 Edition) or diagnosed by histopathological or cytological examinations with inoperable advanced hepatic cholangiocarcinoma, without extrahepatic metastases; Two enhanced imaging (at least three or more (CT/MRI/CEUS) examinations suggest ICC; 3. Must have measurable lesions, defined as at least one lesion that can be accurately measured >=20 mm (CT or MRI scan) in at least one dimension (longest diameter to be recorded); 4. Child-Pugh liver function rating: grade A or better grade B (20cm and = 3 months; 8. The main organs are functioning normally, that is, the following criteria are met: (1) Routine blood examination: (no blood transfusion, no G-CSF, no drug correction within 14 days before screening) a) HB>=90 g/L; b) ANC>=1.5*109/L; c) PLT>=80*109/L; (2) Biochemical examination: (ALB was not lost within 14 days) a) ALB >=29 g/L; b) ALT and AST<5; c) TBIL <=1.5 ; d) Creatinine <=1.5; d) Creatinine <=1.5; 9. Women of childbearing age must take a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate methods of contraception during the test and 8 weeks after the last administration of the test drug. For males, surgical sterilization or consent to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the trial drug; 10. No other malignant tumor complications; 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Participants who have undergone chemotherapy or radiotherapy for ICC; 2. Participants receiving any other anticancer or study drug; 3. Women who are pregnant or breastfeeding; 4. Patients with extrahepatic metastatic disease; 5. Suffering from severe disease that may limit expected survival to less than 3 months; 6. Patients with severe mental illness or social circumstances that would limit compliance with research requirements; 7. Children were excluded from this study because there are currently no data on the dose or adverse events of S-1 + nab-paclitaxel in patients under 18-years old; 8. Patients requiring anticoagulation should receive low molecular weight heparin or standard heparin instead of warfarin; 9. Uncontrolled concurrent diseases, including but not limited to persistent or active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; 10. Pregnant women were excluded from this study because S-1 is a class D drug with potential teratogenic or miscarriage effects. Breastfeeding should be discontinued if the mother is receiving S-1 because the risk of adverse events in the nursing infant after the mother is receiving S-1 is unknown. These potential risks may also apply to other drugs used in this study; 11. HIV-positive individuals receiving antiretroviral combination therapy are ineligible due to possible pharmacokinetic interactions with S-1 + nab-paclitaxel. In addition, these people are at increased risk of developing fatal infections while receiving myelosuppressive therapy. 12. Previously received liver stereotactic radiotherapy; 13. The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1; 14. Severe allergic reactions to other monoclonal antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Progression-free survival;Disease control rate;Overall survival;Improvement of quality of life;Incidence and severity of adverse events;PD-L1 expression; | — |
Countries
China
Contacts
Public Contactli xiaogang
xiangyang central hospital
Outcome results
None listed